About this trial
This is a retrospective observational research study to describe the characteristics and real-world clinical outcomes of patients with chronic lymphocytic leukaemia receiving acalabrutinib in the United Kingdom (the EPIC study). Physicians treating chronic lymphocytic leukaemia patients with acalabrutinib, where the patients started treatment as part of the acalabrutinib Early Access Programme (EAP), will be invited to recruit patients. Clinical data will be extracted from the patients' clinical records in line with local laws. Data from this study will provide UK-specific real-world data on patients who were started on acalabrutinib as part of the UK acalabrutinib EAP.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Treatment-naïve CLL patients who were initiated on acalabrutinib as part of the UK Early Access Programme
Received their first dose of acalabrutinib between 1 April 2020 and 1 April 2021
Patients aged ≥18 years old
Note: patients later found to have small lymphocytic lymphoma (SLL) may also be included in the EAP.
Disqualifiers
None
Trial population
Treatment-naïve adults (≥18 years old) with chronic lymphocytic lymphoma (CLL) who were initiated on acalabrutinib as part of the UK acalabrutiinib early access programme and received their first dose of acalabrutinib between 1 April 2020 and 1 April 2021.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Acalabrutinib
DrugAcalabrutinib
Treatment groups
Trial outcomes
Primary outcomes
Real-world progression free survival (rwPFS)
rwPFS will be defined as the time from index date until earliest record of real-world progression event as determined by physicians' assessment, or death (if no progression) or end of follow-up (for censored observations) whilst on first line treatment.
Real-world progression free survival (rwPFS)
rwPFS will be defined as the time from index date until earliest record of real-world progression event as determined by physicians' assessment, or death (if no progression) or end of follow-up (for censored observations) whilst on first line treatment.
Real-world progression free survival (rwPFS)
rwPFS will be defined as the time from index date until earliest record of real-world progression event as determined by physicians' assessment, or death (if no progression) or end of follow-up (for censored observations) whilst on first line treatment.
Real-world progression free survival (rwPFS)
rwPFS will be defined as the time from index date until earliest record of real-world progression event as determined by physicians' assessment, or death (if no progression) or end of follow-up (for censored observations) whilst on first line treatment.
Secondary outcomes
Real-world overall survival (rwOS)
rwOS will be defined as the time from index date up to death or last date the patient was known to be alive (for censored observations).
Real-world overall survival (rwOS)
rwOS will be defined as the time from index date up to death or last date the patient was known to be alive (for censored observations).
Real-world overall survival (rwOS)
rwOS will be defined as the time from index date up to death or last date the patient was known to be alive (for censored observations).
Real-world overall survival (rwOS)
rwOS will be defined as the time from index date up to death or last date the patient was known to be alive (for censored observations).
Sponsors and contacts
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AstraZeneca
Lead sponsor
UKCLL Forum
Collaborator